FDA Enforcement
Class II
Ongoing
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
Recall: Z-1037-2022
·
Reported May 18, 2022
Enforcement
- Recall Number
- Z-1037-2022
- Event ID
- 89868
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- American Contract Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 18, 2022
- Initiation Date
- March 22, 2022
- Classification Date
- May 6, 2022
- Address
- 2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, 64117-2648, United States
Description
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
Reason
Product was sterilized with a higher than specification EO concentration.
Code Info
1) ACS Arthroscopy Kit - Model LMAR15R, Lot 981221; UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N, Lot 966221; UDI: 00191072150158 3) ACS Hand Pack - Model FHHP63T, Lot 966221, UDI: 00191072149954
Distribution
US Nationwide distribution in the states of IL, MO, NE, and TX.
Quantity
114 packs